The COVID Project
The record
- Jurisdiction
- United States
- Level
- Federal
- Authority
- FD&C Act § 564
- Issued
- 2020-12-18 Dec. 18, 2020
- Effective
- 2020-12-18
- End
- BLA approval (Spikevax) Jan. 31, 2022; EUA continued for other formulations (read as 2022-01-31)
- In force
- Dec. 18, 2020 to Jan. 31, 2022
- Quarters
- 2020 Q42021 Q12021 Q22021 Q3
2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
- Limitation types
- Health care ordersOther
- Addressees
- ModernaTX, Inc.; vaccination providers
- Functions reached
- Collection
- Federal health, safety and transport layer FED-A
Operative words
Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of Moderna COVID19 Vaccine... for the prevention of COVID-19, as described in the Scope of Authorization section (Section II) and subject to the terms of this authorization.
Enforcement
Conditions of authorization
Notes
CONTEXT ONLY. The live FDA letter is the 2024-2025 reissuance (it names the 2023-2024 and 2024-2025 formulas); the December 18, 2020 original date is recited in its history.
Retrieval notecontext; saved letter is a later reissuance.